scholarly journals Novel Method for Benchmarking Recruitment of African American Cancer Patients to Clinical Therapeutic Trials

2008 ◽  
Vol 26 (31) ◽  
pp. 5074-5077 ◽  
Author(s):  
Keith H. Morgenlander ◽  
Sharon B. Winters ◽  
Chyongchiou J. Lin ◽  
Linda B. Robertson ◽  
Dwight E. Heron ◽  
...  

Purpose The National Cancer Institute (NCI) has historically evaluated the participation of underserved minorities within University of Pittsburgh Cancer Institute (UPCI) clinical trials in relation to the proportion of African Americans in the general population of the UPCI primary service area of Allegheny County (12%). This standard seemed to be unrealistically high as a result of a younger age distribution of African Americans within the county. Methods The proportions of African Americans within the following four separate county populations were compared using data from 2000 to 2004: general population; invasive cancer patients; invasive cancer patients diagnosed or treated at UPCI-affiliated facilities; and patients enrolled onto UPCI's clinical therapeutic trials. Results Although the proportion of African Americans within the general population was approximately 13%, only 9.8% of patients diagnosed with invasive cancers were African American. Approximately 9.5% of all cancer patients diagnosed or treated at UPCI facilities were African American, which is comparable to the county-wide percentage of African American cancer patients. Recruitment rate of African Americans to oncology clinical trials from within the UPCI patient population was 7.6%. The NCI benchmark did not reflect the actual invasive cancer incidence rate in African American patients. By comparing the percentage of African Americans contributing to cancer incidence with the percentage of African American cancer patients treated at research-affiliated institutions, a more appropriate benchmark was derived. Conclusion The method developed by UPCI is recommended as a useful mechanism for benchmarking recruitment of African American cancer patients to clinical therapeutic trials at other cancer centers.

2004 ◽  
Vol 22 (4) ◽  
pp. 730-734 ◽  
Author(s):  
Lucile L. Adams-Campbell ◽  
Chiledum Ahaghotu ◽  
Melvin Gaskins ◽  
Fitzroy W. Dawkins ◽  
Duane Smoot ◽  
...  

Purpose African Americans have the highest cancer mortality rates and poorest survival and are more often uninsured and underinsured compared with other ethnic groups. Minority participation in clinical trials has traditionally been low, with reports ranging from 3% to 20%. The present study systematically assesses 235 consecutively diagnosed African American cancer patients regarding recruitment onto cancer treatment clinical trials at Howard University Cancer Center between January 1, 2001, and December 31, 2002. Our intent is to determine the rate-limiting factors associated with enrolling African Americans onto clinical trials at a historically black medical institution. Patients and Methods Two hundred thirty-five consecutively diagnosed African American cancer patients were assessed for participation in clinical trials at Howard University Hospital and Cancer Center. The study population comprised 165 women and 70 men. Results The overall eligibility rate was 8.5% (20 of 235 patients); however, among those eligible, the enrollment rate (ie, enrollment among the eligible population) was 60.0% (12 of 20 patients). Comorbidities rendered 17.1% of the patient population ineligible for the trials. Advanced disease stage, associated with poor performance status, premature death, and short life expectancy, made an additional 10% of the patient population ineligible. Respiratory failure, HIV positivity, and anemia accounted for 37.8% of the comorbidities in this population. Cardiovascular diseases and renal insufficiency represented 16.2% of the comorbidities. Conclusion It was evident that study design exclusion and inclusion criteria rendered the majority of the study population ineligible. Among African Americans, comorbidity is a major issue that warrants considerable attention.


2018 ◽  
Vol 14 (1) ◽  
pp. e1-e10 ◽  
Author(s):  
Narjust Duma ◽  
Jesus Vera Aguilera ◽  
Jonas Paludo ◽  
Candace L. Haddox ◽  
Miguel Gonzalez Velez ◽  
...  

Purpose: Many cancer clinical trials lack appropriate representation of specific patient populations, limiting their generalizability. Therefore, we determined the representation of ethnic minorities and women in cancer clinical trials. Methods: Enrollment data from all therapeutic trials reported as completed in ClinicalTrials.gov from 2003 to 2016 were analyzed. We calculated enrollment fractions (EFs) for each group, defined as the number of enrollees divided by the 2013 Surveillance, Epidemiology, and End Results (SEER) database cancer prevalence. Results: Of 1,012 clinical trials, 310 (31%) reported ethnicity with a total of 55,689 enrollees. Participation varied significantly across ethnic groups. Non-Hispanic whites were more likely to be enrolled in clinical trials (EF, 1.2%) than African Americans (EF, 0.7%; P < .001) and Hispanics (EF, 0.4%; P < .001). A decrease in African American (6% v 9.2%) and Hispanic (2.6% v 3.1%) enrollment was observed when compared with historical data from 1996 to 2002. Younger patients (age younger than 65 years) were more likely to be enrolled in clinical trials than the elderly (64% v 36%; P < .001). Low recruitment of female patients was observed in clinical trials for melanoma (35%), lung cancer (39%), and pancreatic cancer (40%). Conclusion: We observed a decrease in recruitment of minorities over the past 14 years compared with historical data. African Americans, Hispanics, and women were less likely to be enrolled in cancer clinical trials. Future trials should take extra measures to recruit participants that adequately represent the US cancer population.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 2533-2533
Author(s):  
Narjust Duma ◽  
Jesus Vera Aguilera ◽  
Jonas Paludo ◽  
Yucai Wang ◽  
Konstantinos Leventakos ◽  
...  

2533 Background: Many cancer clinical trials (CT) lack appropriate representation of specific patients populations, limiting the generalizability of the evidence obtained. Therefore, we determined the representation of ethnic minorities in oncology CT. Methods: Enrollment data from all therapeutic trials reported as completed in clinicaltrial.gov from 2003 to 2016 were analyzed. CT in rare cancers (< 1% incidence) or with recruitment outside of the US were excluded. Enrollment fraction (EF) was defined as the number of enrollees divided by the 2013 SEER database cancer prevalence. Chi-square test was used to estimate differences in categorical data. Results: Out of 1,012 CT, 310 (31%) reported ethnicity with a total of 55689 enrollees. Distribution by race and comparison with data from 1996-2002, US cancer prevalence and US census are described in the Table. Participation in CT varied significantly across ethnic groups, non-Hispanic Whites (NHW) were more likely to be enrolled in CT (EF of 1.2%) than African Americans (EF of 0.7%, p < 0.001) and Hispanics (EF of 0.4%, p<0.001). A decrease in African Americans (AA) and Hispanics (H) enrollment was observed when compared with historical data from 1996 to 2002. Hispanics were less represented in breast and prostate cancer CT contributing only to 3% and 1.5% of the study population; African Americans were less represented in lung (5.4%) and renal cell carcinoma (3%) trials. Asians were well represented and their recruitment doubled over the past 14 years (2% vs 5.3%). Conclusions: African Americans and Hispanics were less likely to be enrolled in CT. Comparing with historical data; we observed a decrease in minorities’ recruitment in the past 14 years. This change could be attributed to the increased complexity of CT and mandatory molecular testing as many minorities lack access to institutions with genetic testing capacity. Future trials should take extra measures to recruit participants that adequately represent the U.S. cancer population. [Table: see text]


2012 ◽  
Vol 10 (4) ◽  
pp. 279-286 ◽  
Author(s):  
Amy Y. Zhang ◽  
Faye Gary ◽  
Hui Zhu

AbstractObjective:This study examined general and cancer-related stressors of depression that are unique to African-American cancer patients.Method:The study used cohort design and mixed methods. Seventy-four breast and prostate cancer survivors including 34 depressed and 23 non-depressed African-Americans and 17 depressed whites were interviewed. Qualitative data analysis identified themes. The thematic codes were converted to a SPSS data set numerically. The Fisher's exact test was performed to examine group differences in the experience of stress.Results:Significantly more depressed African-Americans experienced a dramatic reaction to a cancer diagnosis (p = 0.03) or had concerns about functional decline (p = 0.01), arguments with relatives or friends (p = 0.02), and unemployment status (p = 0.03) than did non-depressed African-Americans, who reacted to the cancer diagnosis as a matter of reality (p = 0.02). Significantly more depressed African-Americans talked about feeling shocked by a cancer diagnosis (p = 0.04) and being unable to do things that they used to do (p = 0.02) than did depressed whites. Qualitative analysis shed light on the extent of such group differences.Significance of results:Distress from the initial cancer diagnosis and functional decline were likely to have triggered or worsened depression in African-American cancer patients. This study highlighted racial differences in this aspect. It is critical to screen African-American cancer patients for depression at two critical junctures: immediately after the disclosure of a cancer diagnosis and at the onset of functional decline. This will enhance the chance of prompt diagnosis and treatment of depression in this underserved population.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4965-4965
Author(s):  
Gygeria Manuel ◽  
Amy Ayers ◽  
Jonathan Berman ◽  
Shannon Blee ◽  
Claire Sibold ◽  
...  

Abstract Background: Although the incidence of non-Hodgkin lymphoma (NHL) is lower in minority populations, there is a difference in presentation, survivorship and participation in clinical trials (Becnel et al., 2017). African American patients with diffuse large B-cell lymphoma (DLBCL) present with more aggressive features including higher lactate dehydrogenase, increased frequency of B-symptoms, and higher rate of HIV co-infection, while also presenting at a younger age than other patients. (Tiu et al., 2020). Given the association of race with lymphoma presentation and outcomes, minority participation in clinical trials is of vital importance when developing novel therapies. There have been efforts to increase participation of African Americans in cancer clinical trials including patient navigation outreach which resulted in improvement of 9% to 16% of patients approached (Fouad et al., 2016). However, a recent study illustrated that for DLBCL, acute myeloid leukemia, and acute lymphoblastic leukemia, individuals of African descent represented 1.5%, 2.3%, and 6.7% of clinical trial participants, respectively (Gopishetty et al., 2020). We are conducting the current study to identify factors that influence decisions regarding clinical trial participation in African American patients with NHL. Methods: We are identifying African American patients with diffuse large B cell lymphoma and follicular lymphoma who enrolled in a therapeutic clinical trial at Emory University between 2010-2020. We will utilize the electronic medical record to identify patient characteristics such as distance from medical facility, insurance status, type of insurance, comorbidities, education status, type of diagnosis, and race of diagnosing physician. This data will compare African American patients who participated in clinical trials to those who did not participate as part of their initial treatment, specifically comparing baseline characteristics of interest between the groups. Furthermore, the data mention above will be compared between African American and white patients. We are also conducting interviews with a selected group of African American patients that have opted to participate in therapeutic clinical trials to gain a thorough understanding of the barriers and benefits they endured during their experience. The interview questions are based on prior knowledge of clinical trials, distance to facility, religious/ spiritual belief, trust of the physician, additional expenses, and time corresponded to treatment. Patients are asked to rate the importance each factor in their decision to participate and elaborate on points most specific to them. In addition, the interview allows for discussion of possible factors that challenged their participation in clinical trials which may allow for insight on low participation levels nationally. Furthermore, we are going to target patients who enrolled on clinical trials and will subsequently identify patients who did not participate in studies to identify differences in perception of treatment and clinical investigation. This project is partnered with Accounting for the High Enrollment of African Americans in Winship Cancer Institute's Clinical Trials, at Emory University. Conclusions:This study is currently enrolling patients and will answer key questions related to clinical trial participation in African American patients with lymphoma. We aim for the data collected from this study to assist in creating lymphoma clinical trials that better cater to the unique needs and considerations of African Americans. Disclosures Cohen: Genentech, Takeda, BMS/Celgene, BioInvent, LAM, Astra Zeneca, Novartis, Loxo/Lilly: Research Funding; Janssen, Adaptive, Aptitude Health, BeiGene, Cellectar, Adicet, Loxo/Lilly, AStra ZenecaKite/Gilead: Consultancy.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5808-5808
Author(s):  
Volha Mazziotto ◽  
Katrina Mikofalvy ◽  
Alexandra Houck ◽  
Lauren Beck ◽  
Prasad V. Bodas

Abstract Background: African Americans are underrepresented in randomized clinical trials (RCTs). Underrepresentation of this patient group may lead to an inadequate analysis of therapy risks and benefits, and study findings may not be generalizable to a diverse patient population. Moreover, low representation of African Americans in existing clinical trials may discourage future trials focused on this population, as such trials are perceived to be infeasible. Barriers to participation in clinical trials have been extensively studied. Frequently identified factors include: systemic barriers (availability of clinical trials, eligibility barriers, lack of resources), geography (location of the research institution and access to transportation), and individual-level barriers such as low education, poverty, and poor access to healthcare. Willingness to participate has been cited as a major barrier, related to distrust in the US healthcare systemand to cultural and religious beliefs. Yet a dearth of empirical evidence bolsters the assertion that willingness to participate in clinical trials among African Americans is accountable for underrepresentation. We performed a retrospective review of major RCTs focused on sickle cell disease (SCD) in order to measure willingness of African Americans to participate in clinical research. Methods: We systematically identified landmark peer-reviewed RCTs focused on SCD. We analyzed the results of these trials reported in the medical literature and calculated participation and completion rates for each trial. For each study, we identified the number of subjects screened for participation, the number who agreed to participate, and the number who declined. We calculated ratios for study acceptance and study completion. We identified the number of publications which clearly reported data from which acceptance to participate could be directly calculated, the number from which participation could be inferred, or from which reported data were insufficient. Results: We identified 13 RCTs published between 1986 and 2018, representing the major clinically impactful studies in children and adults with SCD. Six of the 13 studies reported sufficient data to infer or calculate participation rates. It is notable that more than half (54%; n=7) of the studies provided insufficient data to calculate study acceptance rates. Our analysis encompassing 2407 patients included in six studies indicates that 82% of subjects with SCD demonstrated willingness to participate in an RCT (range 32-94%), and 95% of clinical trial subjects completed study activities (range 92-98%). Discussion: A minority of publications reported participation data. One of the 13 studies published data on the race of participants, reporting 94% of participants were African American and 3% were Hispanic. However, since SCD predominantly affects African Americans (approximately 90% of those with SCD nationwide are African American and approximately 10% are Hispanic), it is reasonable to estimate that the subjects in our analysis represent a predominantly African American population. We acknowledge that subjects with SCD may not be representative of the US African American population in total. Nonetheless, our findings contradict the assertion that African Americans are less willing to participate in clinical trials, or that African Americans have disproportionately high drop-out rates. Only a minority of publications reported data required to calculate participation rates. Despite this limitation, available empiric evidence suggests that when participation in high-quality clinical trials is made available, African Americans demonstrate a willingness and capacity to enroll and complete study participation. The generalized assertion that African American patients' willingness to participate in research is a major factor in their underrepresentation in clinical trials is false. Researchers should design high-quality clinical trials that include this underrepresented group at the outset, and investigators should be encouraged to collect and report participation data more carefully so that this disparity can be measured and addressed. Disclosures No relevant conflicts of interest to declare.


2020 ◽  
Vol 4 (s1) ◽  
pp. 137-137
Author(s):  
Francesca Christina Duncan ◽  
Catherine Sears ◽  
Nawar Al Narallah ◽  
Ahmad Al-Hader

OBJECTIVES/GOALS: Lung cancer is the leading cause of cancer-related mortality in the United States for both men and women. African Americans are disproportionately affected with lung cancer, having higher incidence and mortality rates compared to Caucasian men and women. African American smokers are diagnosed with lung cancer at a lower age with lower cumulative smoking history. Differences in socioeconomic and environmental factors likely contribute to lung cancer disparities, but less is known about acquired biologic alterations that can promote initiation and progression of lung cancer, particularly in African Americans. This is of interest because there may be other biological, genetic, or environmental factors contributing to lung cancer outcomes as it relates to differences in gender and race. One potential biologic variable may be in the DNA repair capacity (DRC), which describes a cell’s ability to repair damage to DNA caused by carcinogens, oxidants, and radiation. Altered DNA repair is a hallmark of cancer, leading to mutations and malignant transformation. We hypothesize that DRC is decreased in African Americans with lung cancer compared to Caucasian Americans with lung cancer, contributing to the disparity that exists in this racial group. We will 1) perform a retrospective chart review to determine demographic differences between African Americans and Caucasians at three central Indiana hospitals and 2) determine the impact of race and lung cancer on DRC amongst African Americans and Caucasians with and without lung cancer. METHODS/STUDY POPULATION: Lung cancer patients are identified in 3 central Indiana hospitals with different payer source and patient populations using ICD codes. Collected demographics include age, gender, pack-years, lung cancer histology, treatment, and mortality. DRC is measured by host-cell reactivation (non-homologous end-joining and nucleotide excision repair pathways) by flow-cytometry. Measurement of DRC is performed on PBMCs obtained from 120 patients (male and female, African Americans and Caucasians with and without lung cancer). Correlation of DRC and lung cancer will be determined by comparing lung cancer diagnosis to quartile DRC, and adjusted for confounders (measured demographics). Correlative measures will include measures of DNA damage and genomic instability. RESULTS/ANTICIPATED RESULTS: 3450 lung cancer patients were diagnosed with lung cancer at Indiana University Hospital between 1/1/2000 – 5/31/2015. Of these, 48.2% were female and 92.7% smokers. African Americans, Caucasians and Other ethnicities represented 12%, 86% and 2%, respectively. Of smokers, 11.4% were African American. The primary payer source was Federal/Medicare. Retrospective review of lung cancer patients from two additional health systems (county and VA hospitals) will be performed as above with outcomes measured. DRC and additional correlative measures will be performed as in Methods. DISCUSSION/SIGNIFICANCE OF IMPACT: If present, altered DRC in African Americans compared to Caucasians may contribute to the disproportional impact of lung cancer on African Americans. If DRC is decreased in African Americans with lung cancer, future studies will focus on identifying potential genetic, epigenetic and environmental causes for this decrease.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15018-e15018
Author(s):  
Wesley Thompson ◽  
Naeem Latif ◽  
Robert Rahberg

e15018 Background: There are known risk factors for pancreatic cancer like diabetes mellitus; cigarette smoking; poverty, and alcoholism; all of which are more common in African American patients than the general population. The purpose was to determine if these established risk factors were more associated within African American pancreatic cancer patients to explain their 50 – 90% increased incidence in the U.S. population. Methods: This retrospective study reviewed 172 biopsy-proven pancreatic cancer patients diagnosed over ten years at University of Florida Jacksonville. We employed linear regression models to determine statistical significance of established risk factors with prevalence of pancreatic cancer among cohorts. Results: Our data showed no increased association of diabetes, tobacco use, alcohol use between African Americans and Caucasians. However, Africans Americans as a group were twice as likely to be found at stage III or IV upon diagnosis, conferring an increased mortality risk (OR = 2.2, (95% CI 1.1 – 4.39)). Among these African Americans at advanced stage of diagnosis, females were at triple risk by odds ratio to be underinsured compared to Caucasian males (OR = 3.1, (95% CI 1.29 – 7.49, p = 0.015)). African American females were almost twice as likely to be underinsured compared to Caucasian females (OR = 1.72, (95% CI 0.646, 4.558)). The lack of healthcare access maybe related to advanced stage at diagnosis and its increased mortality risk. Conclusions: Our data suggests that the risk factors of smoking, alcoholism, and diabetes mellitus alone do not explain African Americans’ propensity for pancreatic cancer. However, lack of health insurance does confer an advanced stage at diagnosis and increased mortality risk among African American females. Our data also suggests that other etiological factors such as genetics maybe be associated with the increased risk amongst African Americans. A further investigation is warranted into genetic etiologies since African American patients have higher incidence of K-ras mutations than Caucasians; and mutated K-ras has been associated with pancreatic cancer, which is a target for therapy.


2016 ◽  
Vol 12 (6) ◽  
pp. 556-563 ◽  
Author(s):  
Mona N. Fouad ◽  
Aras Acemgil ◽  
Sejong Bae ◽  
Andres Forero ◽  
Nedra Lisovicz ◽  
...  

Purpose: Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute–designated comprehensive cancer center. Methods: Lay individuals were hired and trained to serve as PNs for clinical trials. African American patients potentially eligible for clinical trials were identified through chart review or referrals by clinic nurses, physicians, and social workers. PNs provided two levels of services: education about clinical trials and tailored support for patients who enrolled in clinical trials. Results: Between 2007 and 2014, 424 African American patients with cancer were referred to the Increasing Minority Participation in Clinical Trials project. Of those eligible for a clinical trial (N = 378), 304 (80.4%) enrolled in a trial and 272 (72%) consented to receive patient navigation support. Of those receiving patient navigation support, 74.5% completed the trial, compared with 37.5% of those not receiving patient navigation support. The difference in retention rates between the two groups was statistically significant (P < .001). Participation of African Americans in therapeutic cancer clinical trials increased from 9% to 16%. Conclusion: Patient navigation for clinical trials successfully retained African Americans in therapeutic trials compared with non–patient navigation trial participation. The model holds promise as a strategy to reduce disparities in cancer clinical trial participation. Future studies should evaluate it with racial/ethnic minorities across cancer centers.


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